Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 5, 2007

Last Updated Date

June 5, 2007

Start Date ^†

Current Primary Outcome Measures ^†

fasting plasma glucose, basal insulin levels [ Time Frame: 48 weeks ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

insulin resistance, beta cell function [ Time Frame: 48 week ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

Official Title ^†

Brief Summary

The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Insulin Resistance

Intervention ^†

Drug: metformin, rosiglitazone

Study Arms / Comparison Groups

Publications *

Silic A, Janez A, Tomazic J, Karner P, Vidmar L, Sharma P, Maticic M. Effect of rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus receiving highly active antiretroviral therapy containing protease inhibitor: randomized prospective controlled clinical trial. Croat Med J. 2007 Dec;48(6):791-9.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

documented HIV infection
stable Protease Inhibitor containing HAART regimen for at least 12 months
impaired glucose tolerance
elevated insulin levels (above 20 mIU/l)

Exclusion Criteria:

patients already taking oral hypoglycaemic treatment or insulin
heart failure NYHA I-IV
liver disease or kidney disease
elevated AST or ALT above 2 times upper normal range
elevated creatinine (above 150 mmol/l)

Gender

Male

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Slovenia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00483392

Responsible Party

Secondary IDs ^††

Slovenia grant J3-3545

Study Sponsor ^†

University Medical Centre Ljubljana

Collaborators ^††

Investigators ^†

Study Chair:

Andrej Janez, MD, PhD

Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia

Information Provided By

University Medical Centre Ljubljana

Verification Date

June 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.